Urinary Bladder, Overactive Clinical Trial
— STEPOfficial title:
Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation
Verified date | April 2013 |
Source | Uroplasty, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have completed the 12 weekly treatments of the original protocol, the 13 week follow up assessment, be randomized to the PTNS arm, and be considered a positive responder with moderate or marked improvement in the SUmiT Trial to be enrolled in this study. All consenting responders will continue with active PTNS therapy at an initially prescribed protocol for approximately 3 months followed by individualized symptom-based frequency of visits as determined by the subject along with their treating clinician, for up to a total of 33 months post initial 12-week therapy for a total of 3 years.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects who signed the informed consent and were eligible to participate in the original SUmiT Trial - Subjects who were randomized and treated with the active PTNS therapy during their participation in the original SUmiT Trial - Subject must be a positive responder from initial 12 weekly treatments as prescribed in original SUmiT Trial - 13 week GRA questionnaire must indicate "moderately" or "markedly improved" on question #1 of GRA - Subjects must not have started any antimuscarinics treatment since completion of original SUmiT Trial - Subjects must not have started any urologic Botox treatment since completion of original SUmiT Trial - Subjects must remain off all antimuscarinics throughout participation in trial - Subjects must initiate PTNS maintenance therapy within 2 weeks of their last PTNS treatment as part of SUmiT protocol UPC082008 - Capable of giving informed consent - Capable and willing to follow all study-related procedures for up to 33 months for a total participation of 3 years Exclusion Criteria: - Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period - Subjects who were not able or willing to follow original SUmiT Trial study schedule |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Capital Region Urological Surgeons, PLLC | Albany | New York |
United States | Gregory L. Davis, M.D., FACOG, Inc. | Chico | California |
United States | Urology Health Center, PC | Fremont | Nebraska |
United States | Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan | Grand Rapids | Michigan |
United States | Alliance Urology Specialists | Greensboro | North Carolina |
United States | Greenwich Urological Associates, P.C. | Greenwich | Connecticut |
United States | Athena Urology | Issaquah | Washington |
United States | Mercy Health Partners at the Lakes | Muskegon | Michigan |
United States | Specialists in Urology | Naples | Florida |
United States | Virginia Urology | Richmond | Virginia |
United States | Beaumont Hospital | Royal Oak | Michigan |
United States | Central Missouri Women's Healthcare, LLC | White Plains | New York |
Lead Sponsor | Collaborator |
---|---|
Uroplasty, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline | The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse). | 36 months total | No |
Secondary | GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence. | every three months for 36 months | No | |
Secondary | Change in OAB-q and SF-36 Questionnaires. | every three months for 36 months | No | |
Secondary | Change in Voiding Diary Parameters. | every three months for 36 months | No |
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